Premat Kévin, Dechartres Agnès, Baptiste Amandine, Guedon Alexis, Mazighi Mikael, Spelle Laurent, Denier Christian, Tuilier Titien, Hosseini Hassan, Lapergue Bertrand, Di Maria Federico, Bricout Nicolas, Henon Hilde, Gory Benjamin, Richard Sébastien, Chivot Cyril, Courselle Audrey, Velasco Stéphane, Lamy Mathias, Costalat Vincent, Arquizan Caroline, Marnat Gaultier, Sibon Igor, Lenck Stephanie, Shotar Eimad, Allard Julien, Sourour Nader, Degos Vincent, Alamowitch Sonia, Clarençon Frédéric
Department of Interventional Neuroradiology, Sorbonne Université, APHP, Pitié-Salpêtrière Hospital, Paris, France
Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France.
J Neurointerv Surg. 2025 Mar 17;17(4):360-367. doi: 10.1136/jnis-2024-021502.
Mechanical thrombectomy (MT) has become a standard treatment for acute ischemic strokes (AIS). However, MT failure occurs in approximately 10-30% of cases, leading to severe repercussions (with mortality rates up to 40% according to observational data). Among the available rescue techniques, rescue intracranial stenting (RIS) appears as a promising option.
This trial is poised to demonstrate the superiority of RIS in addition to the best medical treatment (BMT) in comparison with BMT alone, in improving the functional outcomes at 3 months for patients experiencing an AIS due to a large vessel occlusion refractory to MT (rLVO).
Permanent Intracranial STenting for Acute Refractory large vessel occlusions (PISTAR) is a multicenter prospective randomized open, blinded endpoint trial conducted across 11 French University hospitals. Adult patients (≥18 years) with an acute intracranial occlusion refractory to standard MT techniques will be randomized 1:1 during the procedure to receive either RIS+BMT (intervention arm) or BMT alone (control arm).
The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin Scale score ≤2 and evaluated by an independent assessor blinded to the randomization arm. Secondary outcomes include hemorrhagic complications, all adverse events, and death. The number of patients to be included is 346. Two interim analyses are planned with predefined stopping rules.
The PISTAR trial is the first randomized controlled trial focusing on the benefit of RIS in rLVOs. If positive, this study will open new insights into the management of AIS.
NCT06071091.
